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Dressing Wear Time After Reduction Mammaplasty

This study has been completed.
Sponsor:
Collaborator:
Universidade do Vale do Sapucai
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01002391
First received: October 23, 2009
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  Purpose

This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and surgical site infections rates.


Condition Intervention
Surgical Site Infection
Skin Colonization
 Procedure: reduction mammaplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • surgical site infection [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • skin colonization [ Time Frame: 6 days postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postoperative day 1
Dressing is removed on the first postoperative day
 Procedure: reduction mammaplasty
Dressing following reduction mammaplasty is removed on the first postoperative day
Other Name: Breast reduction surgery
Experimental: Postoperative day 6
Dressing is removed on the sixth postoperative day
 Procedure: reduction mammaplasty
Dressing following reduction mammaplasty is removed on the sixth postoperative day
Other Name: Breast reduction surgery

Detailed Description:

Surgical site infections (SSI) are wound infections that occur after invasive procedures.Particularly in plastic surgery procedures, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.

Reduction mammaplasty is an effective and well established procedure performed for the relief of physical pain and discomfort associated with macromastia, which significantly decreases patients' quality of life.Breast reduction has provided long-term relief for most patients, with high patient satisfaction.

The demand for this kind of plastic surgery is high.Reduction mammaplasty was the fifth most commonly surgical procedure performed by plastic surgeons in women of United States.Since reduction mammaplasty is associated with a high incidence of wound problems,all effort to minimize the risk of SSI is valid.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast hypertrophy
  • candidate to reduction mammaplasty
  • body mass index under 30Kg/m2

Exclusion Criteria:

  • pregnancy, delivery or breast feeding during the last 12 months
  • body mass index over 30Kg/m2
  • breast cancer history
  • previous breast surgery
  • hard smoking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002391

Locations
Brazil
Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, Brazil, 37550000
Sponsors and Collaborators
Daniela Francescato Veiga
Universidade do Vale do Sapucai
Investigators
Principal Investigator: Joel Veiga-Filho, MD, MSc Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Study Director: Daniela F Veiga, MD, PhD Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Study Chair: Lydia M Ferreira, MD, PhD Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
  More Information

Publications:

Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01002391     History of Changes
Other Study ID Numbers: dinter01
Study First Received: October 23, 2009
Last Updated: March 12, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
breast hypertrophy
mammaplasty
bandages
surgical site infection
skin colonization

ClinicalTrials.gov processed this record on May 23, 2013